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ID
42061
Description
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 1 Form
Keywords
Versions (3)
- 11/28/17 11/28/17 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
Gruppo Italiano Malattie EMatologiche dell'Adulto
Uploaded on
March 15, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Visit 1 GIMEMA CML0408 NCT00769327
Similar models
Visit 1
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Medication
Item
Medication (Caution: only Hydrossiurea and / or Anagrelide)
text
C0013227 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])
Start date therapy
Item
Start date therapy
date
C3173309 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
End date therapy
Item
End date therapy
date
C1531784 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Pathology
Item
Pathology
text
C0332142 (UMLS CUI [1])
Pathology in progress
Item
Pathology in progress
boolean
C0332142 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,2])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
secondary symptoms
Item
Presence of secondary symptoms to LMC? If yes, indicate which symptoms:
boolean
C1457887 (UMLS CUI [1,1])
C0332138 (UMLS CUI [1,2])
C0332138 (UMLS CUI [1,2])
Asthenia
Item
Asthenia
boolean
C0004093 (UMLS CUI [1])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Sweating
Item
Sweating
boolean
C0038990 (UMLS CUI [1])
Arthralgia
Item
Arthralgia
boolean
C0003862 (UMLS CUI [1])
Nausea
Item
Nausea
boolean
C0027497 (UMLS CUI [1])
Vomiting
Item
Vomiting
boolean
C0042963 (UMLS CUI [1])
Diarrhea
Item
Diarrhea
boolean
C0011991 (UMLS CUI [1])
Weight loss
Item
Weight loss
boolean
C0043096 (UMLS CUI [1])
Abdominal Pain
Item
Abdominal Pain
boolean
C0000737 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Date Physical Exam
Item
Date Physical Exam
date
C2826643 (UMLS CUI [1])
Splenomegaly
Item
Splenomegaly (from the costal bow)
integer
C0038002 (UMLS CUI [1])
Hepatomegaly
Item
Hepatomegaly (from the costal bow)
integer
C0019209 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Complete Blood Count Date
Item
Complete Blood Count Date
date
C0005771 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
integer
C0019046 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
integer
C0023516 (UMLS CUI [1])
Platelets
Item
Platelets
integer
C0005821 (UMLS CUI [1])
polymorphonuclear
Item
polymorphonuclear
integer
C1168338 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0014467 (UMLS CUI [1])
basophils
Item
basophils
integer
C0004827 (UMLS CUI [1])
metamyelocytes
Item
metamyelocytes
integer
C0229635 (UMLS CUI [1])
myelocytes
Item
myelocytes
integer
C0369715 (UMLS CUI [1])
promyelocytes
Item
promyelocytes
integer
C0033416 (UMLS CUI [1])
blasts
Item
blasts
integer
C0368761 (UMLS CUI [1])
Answer hematology
Item
Answer hematology
text
C0474523 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date biochemistry examination
Item
Date biochemistry examination
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
integer
C0201976 (UMLS CUI [1])
Glucose
Item
Glucose
integer
C0202042 (UMLS CUI [1])
LDH
Item
LDH
integer
C0202113 (UMLS CUI [1])
GOT
Item
GOT
integer
C0201899 (UMLS CUI [1])
GPT
Item
GPT
integer
C0201836 (UMLS CUI [1])
y-GT
Item
y-GT
integer
C0202035 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
integer
C0201850 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
integer
C0201913 (UMLS CUI [1])
Amylase
Item
Amylase
integer
C0201883 (UMLS CUI [1])
Lipase
Item
Lipase
integer
C0373670 (UMLS CUI [1])
calcium
Item
Calcium
integer
C0201925 (UMLS CUI [1])
Phosphorus
Item
Phosphorus
integer
C0523826 (UMLS CUI [1])
Potassium
Item
Potassium
integer
C0202194 (UMLS CUI [1])
Magnesium
Item
Magnesium
integer
C0373675 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date Biochemical Examination
Item
Date Biochemical Examination
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
Total Protein
Item
Total Protein
integer
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
integer
C0201838 (UMLS CUI [1])
a1 protein
Item
a1 protein
integer
C0860678 (UMLS CUI [1])
a2 protein
Item
a2 protein
integer
C0301684 (UMLS CUI [1])
beta protein
Item
beta protein
integer
C0005157 (UMLS CUI [1])
gamma protein
Item
gamma protein
integer
C0017007 (UMLS CUI [1])
IgM
Item
IgM
integer
C0202084 (UMLS CUI [1])
IgA
Item
IgA
integer
C0202083 (UMLS CUI [1])
IgG
Item
IgG
integer
C0202087 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date electrocardiogram
Item
Date electrocardiogram
date
C2826846 (UMLS CUI [1])
Electrocardiographic anomalies
Item
Electrocardiographic anomalies
boolean
C1832603 (UMLS CUI [1])
Main electrocardiographic anomaly
Item
Main electrocardiographic anomaly
text
C1832603 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,2])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date echocardiogram
Item
Date echocardiogram
date
C0013516 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Echocardiographic abnormalities
Item
Echocardiographic abnormalities
boolean
C0013516 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Main echocardiographic anomaly
Item
Main echocardiographic anomaly
text
C0013516 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Bone biopsy performed
Item
Bone biopsy performed
boolean
C0005954 (UMLS CUI [1])
Date of bone marrow biopsy
Item
Date of bone marrow biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
Reason biopsy not done
Item
Reason biopsy not done
text
C0332307 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
C0005558 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Stored cell sample
Item
Stored cell sample
boolean
C0370003 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
If not, indicate reasons
Item
If not, indicate reasons
text
C0370003 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C2919806 (UMLS CUI [1,3])
C1698986 (UMLS CUI [1,2])
C2919806 (UMLS CUI [1,3])
Date taken
Item
Date taken
date
C0680532 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0681902 (UMLS CUI [1])
Sample identifier
Item
Sample identifier
integer
C4071975 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Cytogenetics performed
Item
Cytogenetics performed
boolean
C0010802 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason cytogenetics not performed
Item
Reason cytogenetics not performed
text
C0445106 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
Date taken
Item
Date taken
date
C1302413 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
Number of metaphases examined
Item
Number of metaphases examined
integer
C1621812 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0260877 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0260877 (UMLS CUI [1,3])
Ph Phase metaphase number
Item
Ph Phase metaphase number
integer
C0237753 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C0457343 (UMLS CUI [1,2])
Percent metaphase Ph-
Item
Percent metaphase Ph-
integer
C0936012 (UMLS CUI [1,1])
C0025564 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0025564 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Additional abnormalities
Item
Additional abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,2])
Number of metaphases with additional anomalies
Item
Number of metaphases with additional anomalies
integer
C1621812 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Description of Abnormalities
Item
Description of Abnormalities
text
C0678257 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Item Group
FISH (from bone marrow blood)
C0005953 (UMLS CUI-1)
C0162789 (UMLS CUI-2)
C0162789 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
FISH performed
Item
FISH performed
boolean
C0162789 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason FISH not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
Date FISH
Item
Date FISH
date
C0162789 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
CL Item
Sangue Midollare (1)
CL Item
Sangue Periferico (2)
Number of cells analyzed
Item
Number of cells analyzed
integer
C2963401 (UMLS CUI [1])
Number of bcr / abl + cells
Item
Number of bcr / abl + cells
integer
C1835417 (UMLS CUI [1])
Probe used
Item
Probe used
text
C0016321 (UMLS CUI [1])
Classic rearrangement
Item
Classic rearrangement
boolean
C2366845 (UMLS CUI [1,1])
C3250978 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
der (9) deletions
Item
der (9) deletions
boolean
C0495650 (UMLS CUI [1])
Amplification bcr / abl
Item
Amplification bcr / abl
boolean
C3888919 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
Variation shift
Item
Variation shift
boolean
C0205419 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Result description
Item
Result description
text
C0678257 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
Item Group
Molecular Biology (peripheral blood)
C0026376 (UMLS CUI-1)
C0229664 (UMLS CUI-2)
C0229664 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Test performed
Item
Test performed
boolean
C0005834 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason test not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
Date taken
Item
Date taken
date
C1302413 (UMLS CUI [1])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
RT-PCR Result
Item
RT-PCR Result
text
C0599161 (UMLS CUI [1,1])
C2346633 (UMLS CUI [1,2])
C2346633 (UMLS CUI [1,2])
CT BCR/ABL
Item
CT BCR/ABL
integer
C1835417 (UMLS CUI [1])
CT ABL
Item
CT ABL
integer
C1835417 (UMLS CUI [1])
Ratio BCR/ABLx100/ABL
Item
Ratio BCR/ABLx100/ABL
integer
C0456603 (UMLS CUI [1,1])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Nested PCR performed
Item
Nested PCR performed
boolean
C0242574 (UMLS CUI [1,1])
C0599161 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,2])
If yes, write down results
Item
If yes, write down results
text
C1274040 (UMLS CUI [1,1])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
Item Group
FISH (peripheral blood)
C0229664 (UMLS CUI-1)
C0162789 (UMLS CUI-2)
C0162789 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
FISH performed
Item
FISH performed
boolean
C0162789 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
Date FISH
Item
Date FISH
date
C0162789 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
CL Item
Sangue Midollare (1)
CL Item
Sangue Periferico (2)
Number of cells analyzed
Item
Number of cells analyzed
integer
C0022885 (UMLS CUI [1,1])
C0936012 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0007634 (UMLS CUI [1,4])
C0439810 (UMLS CUI [1,5])
C0750480 (UMLS CUI [1,6])
C0936012 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0007634 (UMLS CUI [1,4])
C0439810 (UMLS CUI [1,5])
C0750480 (UMLS CUI [1,6])
Number of bcr / abl + cells
Item
Number of bcr / abl + cells
integer
C1835417 (UMLS CUI [1,1])
C0007584 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0007584 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Probe used
Item
Probe used
text
C0182400 (UMLS CUI [1,1])
C4071975 (UMLS CUI [1,2])
C4071975 (UMLS CUI [1,2])
Classic rearrangement
Item
Classic rearrangement
text
C2366845 (UMLS CUI [1,1])
C3250978 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
der (9) deletions
Item
der (9) deletions
boolean
C0495650 (UMLS CUI [1])
Amplification bcr / abl
Item
Amplification bcr / abl
boolean
C3888919 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
Variation shift
Item
Variation shift
boolean
C0205419 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Result description
Item
Result description
text
C0678257 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])